FDA grants Accelerated Approval for Seagen’s colorectal cancer treatment

pharmafile | January 23, 2023 | News story | Research and Development  

Seagen Inc has been given FDA Accelerated Approval for its colorectal drug TUKYSA (tucatinib) after reviewing positive data from the MOUNTAINEER phase 2 trial. TUKYSA, in combination with trastuzumab, is used for people who have previously been treated for RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer which has progressed following treatments with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.


The FDA’s Accelerated Approval Programme allows for the approval of a medicine based on a surrogate endpoint that is reasonably likely to predict clinical benefit if the medicine fills and unmet medical need for a serious condition; TUKYSA is the first FDA-approved treatment for HER2-positive metastatic colorectal cancer.


Results from the MOUNTAINEER phase 2 trial showed a 38% overall response rate (ORR) per blinded independent central review (BICR) in patients of a median age of 55 (range 27-77 years old) who received TUKYSA in combination with trastuzumab. 3.6% of patients displayed complete responses, with 35% showing partial responses. The median duration of response (DOR) was 12.4 months.


Dr John Strickler, associate professor of medicine at Duke University Medical Center and lead investigator for the MOUNTAINEER trial, said: “Historically, patients with HER2-positive metastatic colorectal cancer, who have progressed following frontline therapy, have had poor outcomes. The FDA approval of a chemotherapy-free combination regimen that specifically targets HER2 is great news for these patients.”


Michal Sapienza, CEO of the Colorectal Cancer Alliance, commented: “Biomarker testing is bringing new hope to people living with some types of colorectal cancer by opening the door to targeted treatments like TUKYSA … It is critical that physicians and patients understand the importance of comprehensive biomarker testing at diagnosis because it can inform treatment decisions and help improve outcomes.”


James Spargo

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